Condition category
Signs and Symptoms
Date applied
27/03/2013
Date assigned
16/04/2013
Last edited
16/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A national survey carried out by the French Society of Anesthesia and Critical Care with INSERM showed that 15% of anesthetic acts in France were due to diagnostic procedures. Several authors have raised this issue because of the cost involved at national level. For invasive diagnostic radiology (angiography), the necessity of the presence of an anesthesiologist is highly controversial. The safety aspect is mentioned but it is questionable because accidents are rare (approximately 0.1%) in those procedures. This explains that, in many centres, an anesthesiologist can be reached in case of an incident but is not present during the whole procedure. Another justification is to improve patient comfort and satisfaction. Some patients do not want to be sedated because of the possibility of post interventional drowsiness and legal constraints related to the anesthetic action (visit 48 hours in advance, monitoring for several hours etc). This uncertainty about the desired level of sedation is reflected in a wide range of anesthesia practices, ranging from simple monitoring to deep sedation for arteriography.
Controlled sedation the patient (also called PCS) is a method derived from patient-controlled analgesia or PCA. The advantage of this technique is to control the patient's level of sedation. This study assesses how well the PCS method works.

Who can participate?
Participants aged under 70 years, with ASA physical status below 3, a scheduled cerebral angiography, and a consultation with an anesthetist at least 48 hours before the procedure.

What does the study involve?
61 patients were randomly allocated to one of two groups: receiving propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).

What are the possible benefits and risks of participating?
Possible benefits were an improve experience of the sedation and fast recovery. Potential risks were insufficient sedation or secondary effects of propofol.

Where is the study run from?
France, Public Hospital of Marseille, neuroradiology operating room.

When is the study starting and how long is it expected to run for?
The study started in January 2000 and was expected to last 6 months.

Who is funding the study?
There was institutional funding from AP-HM, Public Hospital of Marseille, Research Department.

Who is the main contact?
Dr Axel Maurice-Szamburski
axel.maurice@ap-hm.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Axel Maurice-Szamburski

ORCID ID

Contact details

264 rue St. Pierre
Marseille
13009
France
axel.maurice@ap-hm.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00/15

Study information

Scientific title

Effect of patient-controlled sedation with propofol on patient satisfaction: a randomised study

Acronym

Study hypothesis

The aim of this study was to evaluate the difference in patient satisfaction, assessed by a specific and validated scale, using a propofol-based PCS compared to placebo-based PCS for diagnostic cerebral angiography.

Ethics approval

Ethical approval n°:00/15, Chairperson Pr. J-C Manelli, Ethical Committee: CPP Sud-Méditerranée II - Hôpital Salvator, Marseille, France.

Study design

Prospective double blinded randomised

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diagnostic cerebral angiography

Intervention

We randomly assigned 61 patients to receive propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main objective was to evaluate whether a propofol-based PCS would lead at least to 20% difference in patients’ satisfaction on the EVAN scale, which was self reported the day after the procedure.

Secondary outcome measures

Secondary objectives were to assess the quality of patient conditioning by the neuroradiologist and the anesthetist and to report possible side effect.

Overall trial start date

01/01/2000

Overall trial end date

01/07/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age under 70 years
2. ASA physical status below 3
3. Scheduled cerebral angiography
4. Consultation with an anesthetist at least 48 hours before the procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Age under 18 years,
2. Emergency context
3. History of psychiatric disease
4, Long-course anxiolytic treatment
5. Counter-indication to propofol
6. Withdrawal of consent

Recruitment start date

01/01/2000

Recruitment end date

01/07/2000

Locations

Countries of recruitment

France

Trial participating centre

264 rue St. Pierre
Marseille
13009
France

Sponsor information

Organisation

Assistance Publique – Hôpitaux de Marseille AP-HM (France)

Sponsor details

264 rue St.Pierre
Marseille
13005
France

Sponsor type

Hospital/treatment centre

Website

http://www.ap-hm.fr

Funders

Funder type

Hospital/treatment centre

Funder name

Institutional funding from AP-HM, Public Hospital of Marseille, Research Department.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Auquier, P. et al. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology 102, 1116–1123 (2005).
2. Maurice-Szamburski, A., Bruder, N., Loundou, A., Capdevila, X. & Auquier, P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology 118, 78–87 (2013).

Publication citations

Additional files

Editorial Notes